# K970847: Impulse HVG

- Pathway: 510(k) (Traditional)
- Applicant: Armstrong Industries, Inc.
- Decided: Sep 10, 1997 after 187 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) PGS 3000: named in the summary without a submission number

## Indications for use
The Impulse HVG Stimulator can be used to treat and provide therapeutic relief for the following indications: - relaxation of muscle spasm - prevention or retardation of disuse atrophy - increasing local blood circulation, and - maintaining or increasing range of motion The Impulse HVG has the same intended medical uses as the listed predicate device (PGS 3000).

Source page: https://510kreport.com/device/K970847
Methodology: https://510kreport.com/methodology